Tolvaptan - Otsuka Pharmaceutical

Drug Profile

Tolvaptan - Otsuka Pharmaceutical

Alternative Names: Jinarc; Jynarque; OPC 61815; OPC-156; OPC-41061; Samsca; Samsca granules 1%

Latest Information Update: 04 Nov 2018

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At a glance

  • Originator Otsuka America Pharmaceutical; Otsuka Pharmaceutical
  • Class Antihypertensives; Benzazepines; Heart failure therapies
  • Mechanism of Action Diuretics; Vasopressin V2 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Autosomal dominant polycystic kidney disease; Polycystic kidney disease
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Autosomal dominant polycystic kidney disease; Cardiac oedema; Hyponatraemia; Oedema
  • Registered Ascites; Heart failure; Renal failure
  • Phase II Benign prostatic hyperplasia
  • Phase I Unspecified
  • Clinical Phase Unknown Cystinuria

Most Recent Events

  • 17 Aug 2018 Regulatory submission withdrawn for Oedema in Asia (PO) (Otsuka pipeline, August 2018)
  • 02 Aug 2018 European Commission approves for an extension of indication for tolvaptan to include treatment of Autosomal dominant polycystic kidney disease (ADPKD) patients with advanced chronic kidney disease (CKD stage 4) in European Union
  • 29 Jun 2018 CHMP recommends an extension of indication for tolvaptan to include treatment of autosomal dominant polycystic kidney disease (ADPKD) patients with advanced chronic kidney disease (CKD stage 4) in European Union
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